BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2042437 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01413
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS CRT-D WAS TO BE RETURNED FOR ANALYSIS PURPOSES. THE RV LEAD REMAINS ACTIVELY IN SERVICE. THE INVESTIGATION IS CONSIDERED OPEN AT THIS TIME. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE NON-BSC LOCAL AREA SALES REPRESENTATIVE THAT SOME OF THE SETSCREWS ASSOCIATED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE RIGHT VENTRICULAR (RV) AND THE NON-BSC RIGHT ATRIAL (RA) LEADS WOULD NOT LOOSEN. DESPITE MULTIPLE ATTEMPTS WITH VARIOUS WRENCHES, THE DISTAL RV AND SIDE SETSCREWS FOR THE RA LEAD ULTIMATELY REQUIRED THAT THE HEADER BE ENTIRELY REMOVED FROM THE DEVICE. A BONE CUTTER WAS USED TO REMOVED THE DEVICE HEADER. THE NON-BSC RA LEAD COULD NOT BE SALVAGED IN THIS PROCESS. THE RV LEAD APPEARS TO REMAIN IN SERVICE. THERE WAS NO ALLEGATION OF IMPACT ON CRITICAL THERAPY ASSOCIATED WITH THESE CLINICAL OBSERVATIONS, BUT THE NON-BSC RA LEAD HAD TO BE REMOVED FROM SERVICE AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)